About This 510(k) Submission
K243412 is an FDA 510(k) clearance for the ARCHIMEDES Biodegradable Pancreatic Stent, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) (Charlotte, US). The FDA issued a Cleared decision on July 16, 2025, 257 days after receiving the submission on November 1, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.